Z-0007-2013 Class II Terminated
FDA device recall Z-0007-2013 was initiated by Invuity, Inc. on May 12, 2012 and is designated Class II. Reason for recall: Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced … The recall status is terminated (terminated April 23, 2013). Affected quantity: 197 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2012
- Initiation Date
- May 12, 2012
- Termination Date
- April 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 197 devices
Product Description
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Reason for Recall
Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time.
Distribution Pattern
Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.
Code Information
Catalog numbers: 1810000, 1811273, 1811873, 1810873, 18111073 All possible lot numbers: 8Fr: 09061802, 09070201, 09070201, 09101602, 09120701, 10022602, 10030801, 10060102; 10Fr: 09061801, 09070202, 09120702, 09101603, 10022603, 10030802, 10060905, 10060904, 10060103; 12Fr: 09052901, 09061201, 09120703, 09101604, 10022604, 10030803, 10060104.